BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNERGY

    MDR report key: 3040044 · Received April 8, 2013

    Report

    Report Number
    3004209178-2013-04836
    Event Type
    Injury
    Date Received
    April 8, 2013
    Report Date
    March 13, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3998 LOT# L59282, IMPLANTED: 1999 (B)(6), PRODUCT TYPE LEAD PRODUCT ID: 7498-25 LOT# SERIAL# (B)(4), IMPLANTED: 1999 (B)(6), PRODUCT TYPE EXTENSION PRODUCT ID: 3550-09 LOT# *UK6108037, IMPLANTED: 2002 (B)(6), PRODUCT TYPE ACCESSORY PRODUCT ID: 7435 LOT# SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4). NO DEVICE ANALYSIS WAS PERFORMED; THE DEVICE MET RISK BASED CRITERIA.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS REPLACED ON (B)(6) 2011 DUE TO BATTERY DEPLETION. IT WAS NOTED THAT THE PATIENT HAD A ROUTINE APPOINTMENT WITH HER DOCTOR AND HER REPRESENTATIVE REPROGRAMMED HER INS. IT WAS STATED THAT THE PATIENT RECOVERED WITHOUT SEQUELA. IT WAS LATER REPORTED ON (B)(6) 2013 THAT THE PATIENT'S HEALTHCARE PROVIDER (HCP) TOLD HER "SEVERAL WIRES WEREN'T ATTACHED VERY GOOD" AND THEY WERE FIXED DURING THE INS CHANGE ON (B)(6) 2011. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143723 SYNERGY STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7427

    Patients

    Seq Age Sex Outcome Treatment
    1 00078 YR Required Intervention